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CHAPTER 6
CLINICAL LABORATORY LAW Sec5:Classification of Laboratories
 By Function:
RA 4688 (CLINICAL LABORATORY LAW) Clinical Pathology
Approved: June 18, 1966  Hema
A.O. 59 (S.2001)  Immunohema
For preventing the operation & main. of substandard,  ClinChem
improperly managed and poorly equipped Clin. Labs.  BloodBank
Prim. Purpose: To determine the character and quantity of the  Microbio
various chem.. subs. In the blood and other body fluids, tx,  LabEndocrin
secretions and excretions  Para
 Toxi
A.O. 59 S.2001: RULES AND REGULATIONS GOVERNING THE  Myco
ESTAB., OPERATION, AND MAINT. OF CLIN. LABS. IN THE PHIL.  Ther. Drug Monitoring
 ClinMic
 Sec1: Title  Immuno & Sero
 Sec2: Authority Anatomic Pathology
 Sec3:Purpose  SurgPatho
 Sec4:Scope  Immunohistopath
 Sec5:Classification of Laboratories  Cyto
 Sec6:Policies  Autopsy
 Sec7:Requirements & Procedures for Application of  ForensicPatho
Permit to Construct & License to Operate
 Sec8: Violations  By Service Capability:
 Sec9: Investigation of Charges or Complaints Primary (Min.Serv.Cap.)
 Sec10: Modification and Revocation of License  Routine Hema (CBC)
 Sec11: Repealing Clause  Hgb Mass Conc.
 Sec12: Publication of List of Licensed Clinical  Erythro. Vol. Frac. (Hematocrit)
Laboratories  Leuco. No. Conc. (WBC Count)
 Sec13: Effectivity  Leuco. Type No. Fraac. (Diff. Count)
 Qual. Platelet Determination
Sec1: Title  Routine Urinalysis
Rules and Regulations Governing the Establishment,,  Routine Fecalysis
Operation, And Maintenance of Clinical Laboratories in the  Blood Typing
Philippines  Quant. Platelet Determination (Hosp.based)
Secondary (Min. Serv. Cap. Of a primary category)
Sec2: Authority  Routine Clin Chem:
 Issued to implement RA 4688: Clinical Laboratory Law  Blood Gluc. Subs. Conc.
consistent with E.O.102 (S.1999)-Redirecting the Functions  Blood Urea Nitro. Conc.
& Operations of the DOH  Blood Uric Acid Subs. Conc.
 DOH, through BHFS (Bureau of Health Facilities and  Blood Crea. Conc.
Services), shall exercise the reg. functions  Blood Tot. Choles. Conc.
 Cross Matching (Hosp.based)
Sec3:Purpose Tertiary (Sec. Serv. Cap.)
 To protect and promote the health of the people by  Special Chem
ensuring availability of clinical laboratories that are  Special Hema
Properly managed w/ adequate resources  Immuno/Sero
 With effective & efficient performance  Microbio

Sec4:Scope  By Institutional Character:

 Applies to all entities performing all activities and functions Hosp. Based Lab – within the hospital
of clinical laboratories Non-Hosp. Based Laboratory – on its own
 Does not include: government laboratories doing
laboratory exams limited to: Sec6:Policies
 acid fast bacilli microscopy  Approved permit to construct & design layout of a clin.lab.
 malaria screening shall be secured to BHFS (prior to subm. Of Petition to
 cervical cancer screening Operate)

 No clin.lab. shall be constructed until:
-Plans have been approved
-Construction permit issued by BHFS
 Clin.Lab shall operate: w/ a VALID LICENSE issued by
BHFS/CHD (compliance w/ Min. Licensing Requirements)
 Clin.Lab. shall be organized and managed to provide
effective & efficient lab. Serv.
 Clin.Lab. shall provide adeq. & appro. Safety practices for
its personnel & clients
Sec7:Requirements & Procedures for Application of Permit to
Construct & License to Operate
 Application for Permit to Construct
 Letter of Appli. To the BHFS Director
 4sets of Site Dev’t. Plans & Floor Plans
 DTI/SEC Registration (private clinlab)
 Application for New License
 duly notarized application form:”Petition to Establish,
Operate, and Maintain a Clinical Laboratory” shall be
filed by the owner at BHFS
 Application for Renewal of License
 duly notarized application form:”Application for renewal
of license to Establish, Operate, and Maintain a Clinical
Laboratory” shall be filed by the owner at CHD
 Renewal of License (shall be filed w/in 90days b4 exp.d8)
*NCR -- Jan-Mar
*1,2,3 & CAR -- Feb-April
*4,5 &6 -- Mar-May
*7,8 & 9 -- Apr-June
*10,11,12, -- May-July
CARAGA & ARMM
 Permit & License Fees
 Non-refundable license fees:
-Application for permit to construct
-Application for renewal of license to Operate
-License to Operate a gov’t./private clinlab
 Fees shall be paid to BHFS cashier
 Fees shall follow current presc. Sched. Of fees of DOH
 Penalties
 1K: Late renewal (add’l. charge for renewal fee for all
categories IF the application is filed during the next
2mos. After expiration date
 P100: application received more than 2mos after
expiration date (for each month)
 Inspection
 Premises, Facilities: for inspection
 License shall make available to the BHFS Director at:
- any reasonable time
-all pertinent records
 Inspection for every 2years or as necessary
 Monitoring
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 All clinlab shall be monitored regularly
 Records shall be made available to det. Compliance w/
R&R
 BHFS/ CHD Director or his authorized rep.: allowed to
monitor at any given time
 Records for monitoring: All clinlab shall make available
to the Director of BHFS or his authorized rep.
 Issuance of License
 Director of CHD or his authorized rep.: Issuance of
License
 Terms & Conditions of License
 Granted upon compliance w/ licensing requirements
 Non-transferable
 Transfer of clinlab to another location: Owner shall
inform the CHD in writing atleast 15days before actual
transfer
 Clinlab in new loc.: subject for re-inspection & shall
comply w/ licensing req.
 Extension Lab: separate license
 Change affecting substantial conditions of the license
to operate a lab: reported w/in 15days in writing by
persons concerned to BHFS/CHD for NOTATION &
APPROVAL
 Clinlab License: must be placed in a conspicuous
location/area
Sec8: Violations
 Sec. of Health: suspension/revoke of License to Operate
(upon violation of RA4688)
 FF. acts committed by the
owner/president/managers/board of
trustee/director/pathologist/its personnel, are considered
violations:
 Operation of a clinab w/o a cert. pathologist or w/o a
regis. Medtech
 Change of ownership, location, head of lab w/o
informing BHFS and/or CHD
 Refusal to allow inspection of the clinlab
 Gross negligence
 Provincial, City or Municipal Health Officers: authorized
to report to CHD/BHFS any violations
Sec9: Investigation of Charges or Complaints
 BHFS/CHD shall investigate:
 Any person found violating the provisions of RA 4688, the
BHFS/CHD shall:
 Suspend, revoke or cancel the license for a pd. Of time
 criminal action: authority of the offending person, w/o
prejudice to taking the case to judicial authority
 Any person who operates a clinlab w/o proper license from
DOH shall be subject to:
 Imprisonment: 1month-1year
 Fine: 1k-5k
 Both
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 Offender- Firm/Corp.: Managing Head or Owner shall
be liable
 Any clinlab operating w/o a valid license/ license has been
revoked or cancelled shall:
 Summarily closed upon order issued by BHFS/CHD
 Closure order issued by the DOH shall not be rendered
ineffective

Sec10: Modification and Revocation of License

 Revoked/Suspension/Modified in full part of License, for:
 Any mat’l. false statement by the applicant
 Shown by record of inspection
 For a violation/failure to comply any of the terms &
conditions & provisions
Sec11: Repealing Clause
 R&R shall supersede all other prev. off. issuances
Sec12: Publication of List of Licensed Clinical Laboratories
 List of licensed clinlabs shall be published ANNUALY in a
newspaper of gen.circulation
Sec13: Effectivity
 Shall take effect after 15days of publication to off.gazette